21 C.F.R. § 868.5935

Current through October 31, 2024
Section 868.5935 - External negative pressure ventilator
(a)Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
(b)Classification. Class II (performance standards).

21 C.F.R. § 868.5935